Pouch, method of manufacturing a pouch and a method of dispensing a product from a pouch

ABSTRACT

A single-use pouch ( 10 ) for liquid product has a front panel ( 12 ) and a back panel ( 14 ). The front and back panels at least in part cooperatively define an interior space ( 15 ) of the pouch. The interior space has a total liquid capacity. A volume of liquid product is contained within the interior space. The volume of liquid product is less than about 60% of the total liquid capacity of the pouch.

This application claims priority to U.S. Provisional Application No.61/427,526, filed Dec. 28, 2010, the disclosure of which is hereinincorporated by reference in its entirety.

FIELD OF THE DISCLOSURE

The field of this disclosure relates generally to packaging for liquidproducts and more particularly to a pouch for containing and dispensingaseptically processed low acid concentrated liquid (e.g., human milkfortifier), methods for manufacturing a hermetically sealed pouch,methods for aseptically packaging the human milk fortifier in the pouch,method for testing of seal integrity of the pouch and methods of usingthe pouch to dispense human milk fortifier.

BACKGROUND OF THE DISCLOSURE

Human milk is generally recognized as an ideal food source for mostinfants due to its overall nutritional composition. It is well known andgenerally accepted that human milk provides infants with uniqueimmunologic and developmental benefits as compared generally tocommercially available infant formulas.

For some infants, however, especially preterm infants, human milk doesnot always meet their complete nutritional needs. Although these infantsstill generally benefit from human milk, it is often desirable tosupplement their human milk feedings with additional nutrients.Initially, preterm infants may grow more rapidly than many of their termcounterparts, and accelerated growth often requires additionalnutrition, which can be made possible by the use of a human milkfortifier in combination with human milk.

Human milk fortifiers described in literature and commercially availablehave been formulated as reconstitutable powders rather than liquids inorder to minimize the volume displacement of human milk by thefortifier. Powdered human milk fortifiers, however, are not consideredcommercially sterile therefore microbes can be present in powdered humanmilk fortifiers and may grow once dispensed from the package into thehuman milk.

More recently, liquid human milk fortifiers, and specifically highlyconcentrated human milk fortifier liquids, have received more attentionas an alternative to powders. Although these highly concentrated humanmilk fortifiers do generally displace slightly more volume than powders,the liquids are processed to be commercially sterile, which is not anoption for powders.

Hydrolyzed proteins are often desirable to utilize in human milkfortifiers as they are generally more easily digested and absorbed intothe gut of a preterm infant as compared to substantially intactproteins. Additionally, the hydrolyzed proteins may be hypoallergenicsuch that they may not predispose the infant to cow's milk allergieslater in life. However, as compared to intact proteins, extensivelyhydrolyzed proteins (i.e., proteins having a degree of hydrolysis ofabout 20% or more) tend to have poor ability to form long term stableemulsions. Additionally, the presence of high levels of insolubleminerals such as calcium salts may also cause a number of stabilityissues when used in combination with extensively hydrolyzed proteins. Assuch, manufacturing long term stable liquid concentrated human milkfortifiers including extensively hydrolyzed proteins have provendifficult.

To combat this problem, many liquid human milk fortifiers have beenmanufactured with stabilizers, such as carrageenan. The stabilizers actto hold the nutrients and insolubles in solution over time and thusimprove long term stability of the product. Although stabilizers, suchas carrageenan, have generally proven to retard precipitation of manyingredients in the liquid human milk fortifier, these types ofstabilizers are not permitted in infant formulas and human milkfortifiers in many countries around the world. When stabilizers cannotbe used in highly concentrated human milk fortifiers, it can be verydifficult to produce a long term stable highly concentrated human milkfortifier.

As such, there is a need for liquid human milk fortifiers that arecommercially sterile, do not require refrigeration, and have relativelylow acidity. In addition, there is a need for packaging for liquid humanmilk fortifiers that is sufficiently flexible to allow insitu mixing ofthe fortifier, and transparent so that a user can visually observe thehuman milk fortifier to ensure proper mixing has occurred before openingthe packaging to dispense the human milk fortifier. Moreover, thepackaging should be easy to use and should minimize the amount ofresidual human milk fortifier remaining in the packaging after dosing.

BRIEF DESCRIPTION OF THE DISCLOSURE

In one aspect, a single-use pouch for liquid product generally comprisesa front panel and a back panel. The front and back panels at least inpart cooperatively define an interior space of the pouch. The interiorspace has a total liquid capacity. A volume of liquid product iscontained within the interior space. The volume of liquid product isless than about 50% of the total liquid capacity of the pouch.

In another aspect, a single-use pouch for liquid product generallycomprises a front panel and a back panel. The front and back panels atleast in part cooperatively define an interior space of the pouch. Theinterior space has a total liquid capacity. A volume of liquid productand gas is contained within the interior space. The volume of liquidproduct and gas is less than about 40% of the total liquid capacity ofthe pouch.

In yet another aspect, a pouch generally comprises a front panel and aback panel. The front and back panels at least in part cooperativelydefine an interior space of the pouch. At least one of the front paneland the back panel is made at least in part from a flexible, transparentmaterial. An aseptically processed liquid product is contained withinthe interior space of the pouch and visually observable through the atleast one of the front panel and the back panel.

In still another aspect, a method of packaging an aseptic liquid productinto a pouch generally comprises sterilizing both sides of a flexibleand transparent web of sheet material with a sterilant. The web is drawnacross forming shoulders, around filling tubes, to create longitudinalpouch tubes. Two pouches are formed, one from each lane. Each pouch isfilled with an aseptically processed liquid product.

In still yet another aspect, a method of dispensing a liquid productfrom a pouch generally comprises obtaining a pouch having an asepticallyprocessed liquid product contained therein. At least a portion of thepouch is transparent for allowing visual observation of the liquidproduct contained therein. The pouch is manually kneaded to mix theliquid product within the pouch. The liquid product is visually observedthrough the transparent portion of the pouch to determine if the liquidproduct has been sufficiently mixed. The pouch is opened and the liquidproduct is poured from the pouch.

In still a further aspect, a single-use pouch for product generallycomprises a body having a front panel and a back panel. The front andback panels at least in part cooperatively define an interior space ofthe pouch for containing the product. A spout is in fluid communicationwith the interior space. Product is dispensed from the pouch through thespout. The spout has a width and the body has a width wherein the ratioof the width of the body and the width of the spout is between about 3:1and about 5:1.

In yet a further aspect, a secondary container for holding a pluralityof pouches generally comprises a base section and a lid hingely attachedto the base section for movement between a closed position and an openedposition. A pair of hold downs are disposed adjacent opposite ends ofthe hinge.

In still another aspect, a secondary container for holding a pluralityof pouches generally comprises a base section and a lid hingely attachedto the base section for movement between a closed position and an openedposition. The base section includes a bottom wall, at least one sidewall extending up from the bottom wall, a top wall, and an interiorfloor. The interior floor is tented along its center line.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective of one suitable embodiment of a pouch forcontaining and dispensing a liquid product, the pouch being illustratedin a closed configuration;

FIG. 2 is a front elevation thereof;

FIG. 3 is a back elevation thereof;

FIG. 4 is a cross-section taken along line 4-4 of FIG. 2;

FIG. 5 is a cross-section taken along line 5-5 of FIG. 2;

FIG. 6 is a front elevation similar to FIG. 2 but illustrating the pouchin an opened configuration;

FIG. 7A is an enlarged fragmentary cross-section taken along line 7-7 ofFIG. 3 illustrating one suitable laminate for forming the pouch;

FIG. 7B is an enlarged fragmentary cross-section similar to FIG. 7A butillustrating another suitable laminate for forming the pouch

FIG. 8 is a front elevation of another suitable embodiment of a pouchfor containing and dispensing a liquid product, the pouch beingillustrated in a closed configuration;

FIG. 9 is a front elevation of another suitable embodiment of a pouchfor containing and dispensing a liquid product, the pouch beingillustrated in a closed configuration

FIG. 10 is a flow diagram illustrating one suitable embodiment of aprocess for manufacturing the pouch and filling the pouch with a liquidproduct;

FIGS. 11A-11C are schematics illustrating sequential aspects of theprocess for manufacturing and filling the pouch;

FIG. 12 is a perspective of one suitable embodiment of a secondarypackaging for containing a plurality of the pouches;

FIG. 13 is a perspective illustrating the pouch in its openedconfiguration and the liquid product contained therein being dispensedinto a nursing bottle containing human milk;

FIGS. 14A and 14B are side elevations of pouches similar to the onesillustrated in FIGS. 2 and 9 except that the pouches seen herein areopaque;

FIGS. 15A and 15B illustrate the pouch of FIG. 14A in the process ofbeing opened and being tilted as if the product contained therein isbeing dispensed;

FIGS. 16A and 16B illustrate another suitable embodiment of a secondarypackaging for containing a plurality of the pouches illustrating a lidof the packaging in a closed position and in an opened position;

FIG. 17 is a front perspective view of the secondary packaging of FIG.12 with the lid closed;

FIG. 18 is another front perspective of the secondary packaging of FIG.12 with the lid closed;

FIG. 19 is a rear perspective of the secondary packaging of FIG. 12 withthe lid closed;

FIG. 20 is a front perspective of the secondary packaging of FIG. 12with the lid opened;

FIG. 21 is a side elevation of the secondary packaging of FIG. 12 withthe lid opened;

FIG. 22 is a schematic illustration of a plastic container including aconcentrated liquid human milk fortifier that does not contain anyOSA-modified corn starch or low acyl gellan gum;

FIG. 23 is a schematic illustration of a plastic container including aconcentrated liquid human milk fortifier that contains OSA-modified cornstarch but does not contain low acyl gellan gum;

FIG. 24 is a schematic illustration of a plastic container including aconcentrated liquid human milk fortifier that contains low acyl gellangum but does not contain OSA-modified corn starch; and

FIG. 25 is a schematic illustration of a plastic container including aconcentrated liquid human milk fortifier that contains both OSA-modifiedcorn starch and low acyl gellan gum.

Corresponding reference characters indicate corresponding partsthroughout the drawings.

DETAILED DESCRIPTION OF THE DRAWINGS Pouch

FIGS. 1-5 of the drawings illustrate one embodiment of a pouch,indicated generally at 10, suitable for packaging and dispensing aliquid product, e.g., a liquid product intended for human consumption.As used herein “liquid product” means a product that is a flowablenon-solid product including, for example but not limited to, aqueoussolutions, solutions having a determinable viscosity, emulsions,colloids, pastes, gels, dispersions and other flowable non-solidproducts so as to exclude solid products such as bars and particulateproducts, such as powders.

As seen therein, the illustrated pouch 10 has a front panel 12 and aback panel 14 generally opposed to and sealingly engaged with the frontpanel to at least in part define an interior space 15 sized and shapedfor containing the product. The illustrated pouch 10 comprises two sideedges 16, 18, two end edges 20, 22, a longitudinal axis LA, and atransverse axis TA. In the illustrated embodiment, the pouch 10 isformed from a single-piece of sheet material that has been folded abouta longitudinal fold line. As seen in FIGS. 2-5, the fold line forms oneof the side edges 16 of the pouch 10. The front panel 12 of the pouch 10is joined to the back panel 14 along the other side edge 18 and at theend edges 20, 22 along a plurality of seal lines 25, such as by heatsealing, to seal the interior space 15 of the pouch. It is understood,however, that the front panel 12 and back panel 14 of the pouch 10 maybe joined in other ways without departing from the scope of the presentinvention (e.g., adhesive). It is also understood that the pouch 10could be formed from two separate panels that are sealed together alongboth side edges 16, 18 and the end edges 20, 22. It is also contemplatedthat the pouch 10 may include sidewalls (not shown) intermediate thefront panel 12 and the back panel 14 without departing from the scope ofthis invention.

With reference to FIGS. 2 and 3, the seal lines 25 include end segments25 a, 25 b disposed along the margins adjacent the end edges 20, 22 ofthe pouch 10, respectively, to fluidly seal the ends of the pouch. Aside edge segment 25 c is disposed adjacent one of the side edges 18(i.e., opposite the side edge 16 defined by the fold line) and extendsthe longitudinal length of the pouch 10. The side edge segment 25 cintersects (or otherwise contacts) the end segments 25 a, 25 b to definethe interior space 15 of the pouch 10 and to seal the pouch in afluid-tight manner. As seen in FIGS. 2 and 3, the seal lines 25 furthercomprise an inboard seal segment 25 d that connects one of the endsegments 25 a (the upper seal segment as viewed in FIGS. 2 and 3) to theside edge segment 25 c. In the illustrated embodiment, the inboard sealsegment 25 d includes a longitudinal component 25 d′ extending downwardfrom the end segment 25 a and a diagonal component 25 d″ extendingdiagonally from the longitudinal component to the side edge segment 25c. It is understood, however, that the inboard seal segment 25 d canhave different configurations (e.g., generally L-shaped) withoutdeparting from the scope of this invention.

With reference still to FIGS. 2 and 3, the pouch 10 includes a body 60,a spout 62, and a transition (or funnel) portion 64 connecting the bodyto the spout. The body 60 is the portion of the pouch 10 below the lowerextent of the diagonal component 25 d″ of the inboard seal segment 25 dof the seal lines 25. The body 60 has a height H1 and a width W1. In theillustrated embodiment, the height H1 of the body 60 is approximately 75mm and the width W1 of the body is approximately 36 mm. It is understoodthat the body 60 can have heights and widths less than or greater thanthe exemplary heights and widths provided herein. The spout 62 isdefined by the end segment 25 a and the longitudinal component 25 d′ ofthe inboard seal segment 25 d of the seal lines 25. As seen in FIGS.2-4, the spout 62 includes the fold line defining one of the side edges16 of the pouch 10. In use, the fold line acts as a channel and guidesthe product along the fold line and towards an opening in the spout. Thespout 62 has a height H2 and a width W2. In the illustrated embodiment,the height H2 of the spout 62 is approximately 17 mm and the width W1 ofthe spout is approximately 10 mm. Thus, the illustrated body 60 of thepouch 10 has a width ratio of about 3.6:1 with respect to the width ofthe spout 62. That is, the body has a width that is about 3.6 timeslarger than the width of the spout 62. It is understood that the spout62 can have heights and widths less than or greater than the exemplaryheights and widths provided herein. For example, the ratio of the widthof the body and the width of the spout may be between about 3:1 andabout 5:1, such as, about 4:1.

The transition portion 64 is a portion of the pouch 10 disposed betweenthe spout 62 and body 60, and includes the diagonal component 25 d″ ofthe inboard seal segment 25 d of the seal lines 25. In use, the diagonalcomponent 25 d″ of the inboard seal segment 25 d acts as a funnel-likesurface to funnel the product towards the spout. The transition portion64 has a height H3. In the illustrated embodiment, the height H3 of thetransition portion 64 is approximately 17 mm. The width of thetransition portion 64 reduces along its height as it extends from thebody 60 to the spout 62. It is understood that the transition portion 64can have heights and widths less than or greater than the exemplaryheights and widths provided herein.

In a sealed (broadly, closed) configuration of the pouch 10, asillustrated in FIGS. 1-3, the product is sealingly enclosed in theinterior space 15 of the pouch. In one suitable embodiment, the productis aseptically processed and sealed within the pouch 10 as described inmore detail below. The pouch 10 can be selectively configured from thesealed configuration to an opened configuration as illustrated in FIG. 6to permit dispensing of the product from the pouch. In one suitableembodiment, the product is a liquid and can be poured from the pouch 10through the spout 62. It is understood, however, that the product can beany suitable, liquid substance including a gel or a paste.

As illustrated in FIGS. 1-3, the pouch 10 has a first line of weakness30 formed on the front panel 12 of the pouch and a second line ofweakness 32 formed on the back panel 14 of the pouch. The lines ofweakness 30, 32 provide a path along which the pouch 10 is more readilytorn to open the pouch (i.e., configured to the opened configuration).It is understood that the pouch 10 may have a line of weakness 30, 32disposed on only one of the front and back panels 12, 14, with the otherpanel being free of a line of weakness and remain within the scope ofthis invention. While the lines of weakness 30, 32 in the illustratedembodiment are substantially equal in length, the lengths of the linesof weakness 30, 32 can be different without departing from the scope ofthis invention. Thus, the line of weakness 30 on the front panel 12 ofthe pouch 10 may be longer or shorter than the line of weakness 32 onthe back panel 14 of the pouch.

In the illustrated embodiment, the lines of weakness 30, 32 comprisescore lines. The term “line of weakness” is used herein to mean anydefined (e.g., intended) structural feature that weakens the pouch 10along a predetermined path so that the pouch 10 is more readilyruptured, or torn, upon application of a tearing force along the line ofweakness and is not limited to score lines. For example, in otherembodiments, the lines of weakness 30, 32 may comprise a plurality ofseparation points, a score line, a breakaway line or areas, a chainstitch, a thinning of the pouch material, a plurality of alignedperforations (e.g., holes, slits, apertures, voids, or the like) orother suitable line of weakness. The lines of weakness 30, 32 may beformed by partial pressure cutting, partial ultrasonic cutting, partialthermal deformation, mechanical thinning, or other suitable techniques.

As mentioned, the lines of weakness 30, 32 provide a path of lowresistance along which the pouch 10 may be torn. However, the level ofresistance to tearing provided by the lines of weakness 30, 32 can bealtered. Lowering the tear resistance would make the pouch 10 easier toopen. As a result, less force is needed to tear the pouch 10 along thelines of weakness 30, 32. However, lowering the tear resistance mayincrease the risk that the pouch 10 will unintentionally tear apart orotherwise leak. On the other hand, increasing the resistance of thelines of weakness 30, 32, would require a greater force to tear thepouch 10 along the lines of weakness. In addition, the lines of weakness30, 32 can have varying tear resistance along their length or a portionof their length. In addition, the tear resistance of the line ofweakness 30 in the front panel 12 of the pouch 10 may be equal to ordifferent than the tear resistance of the line of weakness 32 in theback panel 14 of the pouch.

In the illustrated embodiment, the lines of weakness 30, 32 begin at theside edge 18 (e.g., the side edge not defined by the fold line), extendthrough the side edge segment 25 c of the seal lines 25 and generallyparallel to but spaced from one of the end edges 20, and terminatewithin the longitudinal component 25 d′ of the inboard seal segment 25 dof the seal lines and generally adjacent the spout 62. Accordingly, theproduct can be accessed by tearing the pouch 10 along the lines ofweakness 30, 32 as illustrated in FIG. 6. The spout 62 is tornapproximately in half longitudinally during tearing of the lines ofweakness 30, 32. It is understood, however, that more or less of thespout 62 can be torn away.

In the illustrated embodiment, the portion of the pouch 10 above thelines of weakness 30, 32 defines a gripping portion 66 suitable formanually grasping to facilitate opening of the pouch 10 by tearing alongthe lines of weakness 30, 32. In one suitable embodiment, the grippingportion 66 is removed from the remainder of the pouch 10 when the pouchis opened (i.e., when the pouch is torn along the lines of weakness 30,32). It is contemplated, however, that the gripping portion 66 canremain connected to the pouch 10 so long as the spout 62 is sufficientlyopen to allow the product to flow out of the interior space 15 of thepouch.

The pouch 10 may be formed from any suitable material including wovenmaterial, non-woven material, films, laminates, or a combinationthereof. For example, in one suitable embodiment, the pouch 10 comprisesa two layered laminate having an inner layer 50 and an outer layer 52(FIG. 7A). In one particularly suitable embodiment, the inner layer 50is formed from a co-extrusion of linear low density polyethylene (LLDPE)and ethylene vinyl alcohol (EVOH), and the outer layer 52 from barriercoated polyethylene terephthalate (PET). In another suitable embodiment,which is illustrated in FIG. 7B, the pouch 10 comprises a three layeredlaminate having an inner layer 50′, an outer layer 52′, and anintermediate layer 54′ disposed between the inner and outer layers (FIG.7B). In one particularly suitable embodiment, the inner layer 50′ isformed from a co-extrusion of linear low density polyethylene (LLDPE)and ethylene vinyl alcohol (EVOH), and the outer layer 52′ from barriercoated polyethylene terephthalate (PET). The intermediate layer 54′ isformed from one of aluminum oxide coated PET, a silicon oxide coatedPET, or ethylene vinyl alcohol. As explained in more detail below, thepouch 10, in one suitable embodiment, is formed from a non-metallicmaterial. That is, the pouch 10 is substantially free from metal. It isunderstood, however, that the layers 50, 50′, 52, 52′, 54′ can be formedfrom any suitable materials without departing from some aspects of thisinvention.

As seen in FIG. 7A, the layers 50, 52 of the two layer laminate arebonded together using adhesive 51. It is understood, however, that thelayers 50, 52 can be bonded together using other suitable techniques. Asalso seen in FIG. 7A, indicia 53 is printed on an inner surface of theinner layer 50 (i.e., the surface that faces and is bonded to the outerlayer 52) using suitable ink. It is understood, however, that theindicia 53 can be printed on either surface of the outer layer 52.

In one suitable embodiment, at least a portion of the pouch 10 isgenerally transparent to permit visual observation of the productcontained therein. In the illustrated embodiment, for example, theentire pouch 10 is generally transparent. In one suitable embodiment,the inner surface of the inner layer 50 of either the front panel 12 orthe back panel 14 can be covered with a white ink to render thefront/back panel generally transparent. It is understood, however, thatless then the entire pouch can be transparent. For example, the frontpanel 12 could be made from a generally transparent material and theback panel 14 formed from a translucent or opaque material, or viseversa. In another example, the pouch 10 could include a longitudinallyextending strip of transparent material (e.g., to form a window) oneither one of or both the front and back panels 12, 14 of the pouchwhile the remainder of the pouch is formed from a generally translucentor opaque material. It is understood, that the pouch 10 can be formedfrom generally opaque material as seen in FIGS. 14A and 14B withoutdeparting from some aspects of this invention.

The pouch 10 illustrated in FIGS. 1-6 is suitably configured forcontaining and dispensing a predetermined target dispensing dosage, suchas, approximately 5 ml. It is understood, however, that the pouch 10 canbe configured to hold any suitable target dosage. For example, FIG. 8illustrates a second embodiment of a pouch 110 substantially similar tothe pouch 10 of FIGS. 1-6 except that the pouch of this secondembodiment is smaller and designed to hold a target dosage ofapproximately 2 ml. More specifically, the pouch 110 has a shorter body160 than the body 60 of the pouch 10 illustrated in FIGS. 1-6.Otherwise, the pouches 10, 110 are substantially the same including, inone embodiment, being of the same width for ease of manufacturingdifferent sized pouches. In another example, FIG. 9 illustrates a thirdembodiment of a pouch 210 substantially similar to the previousdescribed pouch 10 of FIGS. 1-6 except that the pouch of this embodimentis larger and designed to hold a target dosage of approximately 80 ml.More specifically, the pouch 210 has a longer body 260 than the body 60of the pouch 10 illustrated in FIGS. 1-6. Otherwise, the pouches 10, 210are substantially the same. Depending on the product and the desiredtarget dosage, it is understood that the pouch may be sized andconfigured for generally any target dosage.

In one suitable embodiment, each of the pouches 10, 110, 210 is filledwith a greater quantity of product as compared to its intended targetdispensing dosage to account for residual product that remains withinthe pouch after use, such as, due to viscosity and stickiness of theproduct. Testing of the pouch 10 illustrated in FIGS. 1-6 determinedthat approximately 88 percent of the pouch contents are typicallydispensed during use. As a result, each of the pouches 10, 110, 210 hasan actual fill volume that is approximately 12 percent greater than thetarget dispensing dosage. Thus, the pouch 110 intended to have a 2 mldosage (FIG. 8) has a fill volume of approximately 2.27 ml. The pouch 10intended to have a 5 ml dosage (FIGS. 1-7) has a fill volume ofapproximately 5.69 ml. And the pouch 210 intended to have an 80 mldosage size (FIG. 9) has a fill volume of approximately 90.91 ml. It isunderstood that the pouches 10, 110, 210 can have other anticipatedresidual rates (i.e., besides 88 percent) as a result of viscosity,stickiness or other factors and thus other fill volumes withoutdeparting from the scope of this invention.

Moreover, it is anticipated that each of the pouches 10, 110, 210 willhave a distribution ratio within ±4 percent. That is, the actual amountof product distributed from each of the pouches 10, 110, 210 will bewithin 4 percent of the target dosage for that pouch. Thus, the pouch110 intended to have a 2 ml dosage (FIG. 8) will actually dispense aquantity of product between about 1.92 ml and about 2.08 ml. The pouch10 intended to have a 5 ml dosage (FIGS. 1-7) will actually dispense aquantity of product between about 4.8 ml and about 5.2 ml. And the pouch210 intended to have an 80 ml dosage (FIG. 9) will actually dispense aquantity of product between about 76.8 ml and about 83.2 ml. It isunderstood that the pouches 10, 110, 210 can have a differentdistribution ratio (i.e., besides ±4 percent) without departing from thescope of this invention.

Each of the pouches 10, 110, 210 is capable (e.g., sufficientlyflexible) of being manually kneaded or otherwise manipulated by a userto ready the product within the pouch before opening the pouch. Thus, inone embodiment, the product can be thoroughly mixed within the pouch 10,110, 210 before the pouch is opened and the product dispensed therefrom.In other embodiments where the product is more gel-like, kneading also,or alternatively, thins the product to render it easier to pour. In onesuitable embodiment, the front and back panels 12, 14 of the pouch 10contact each other during the kneading process under relatively light,manual pressure and the product is able to move freely throughout theinterior space 15.

A qualitative kneadability study was performed on pouches designed for atarget dispensing dosage of about 5 ml. The pouches had a total (e.g.,maximum) liquid capacity of about 20 ml. In Example 1, ten pouches werefilled with a various amount of air (broadly, a gas) and manuallykneaded. The kneadability of the pouch was rated as being easy,moderate, difficult or extremely difficult. The amount of air and theresults of the testing are provided in the following Table. In Example2, ten pouches were filled with a various amount of liquid and manuallykneaded. The kneadability of the pouch was rated as being easy,moderate, difficult or extremely difficult. The amount of liquid and theresults of the testing are provided in the following Table. In Example3, ten pouches were filled with various combinations of liquid and airand manually kneaded. The kneadability of the pouch was rated as beingeasy, moderate, difficult or extremely difficult. The amount of liquidand air and the results of the testing are provided in the followingTable.

Example 1

Air Only Sample Air Volume (ml) Total Volume Ease of Kneading 1 6 6 Easy2 7 7 Easy 3 8 8 Easy 4 9 9 Easy 5 10 10 Easy 6 11.5 11.5 Moderate 716.5 16.5 Moderate 8 19 19 Moderate 9 22 22 Difficult 10 26.5 26.5Extremely Difficult

Example 2

Liquid Only Sample Liquid Volume (ml) Total Volume Ease of Kneading 1 44 Easy 2 5 5 Easy 3 6 6 Easy 4 7 7 Easy 5 8 8 Easy 6 9 9 Easy 7 10 10Easy 8 12 12 Moderate 9 16 16 Difficult 10 20 20 Extremely Difficult

Example 3

Liquid + Air Air Volume (ml)/ Total Liquid Vol = 5.56 ml % Air VolumeVolume Ease of Kneading 1 0.6/10% 6.2 Easy 2 1.4/20% 7.0 Easy 3 2.4/30%7.9 Easy 4 3.7/40% 9.3 Easy 5 5.6/50% 11.1 Easy 6 8.3/60% 13.9 Moderate7 10.3/65%  15.9 Moderate 8  13/70% 18.5 Difficult 9 16.7/75%  22.2Extremely Difficult 10 22.2/80%  27.8 Extremely Difficult

The intent of the kneadability study was to determine suitable packagedvolumes at which kneading of the product/pouch becomes impractical(i.e., difficult or extremely difficult).

As seen above for Example 2, where no air is present the amount ofliquid within the pouch should be less than or equal to about 50% of thetotal liquid capacity of the pouch. When the amount of liquid in thepouch exceeded 50%, the kneadibility of the pouch was reduced. In onesuitable embodiment, the volume of liquid in the pouch is between about20% and about 50%, more suitably between about 30% and about 40%, andeven more suitably about 35% of the total liquid capacity of the pouch.

As seen above for Example 3, the total volume taken up by liquid and gas(e.g., air) within the pouch should be less than or equal to about 50%of the total liquid capacity of the pouch. When the combined volume ofliquid and gas exceeds about 50%, the kneadibility of the pouch isreduced. In one suitable embodiment, the combined volume of liquid andgas in the pouch is between about 10% and about 50%, more suitablybetween about 20% and about 40% of the total liquid capacity of thepouch.

Human Milk Fortifiers

Concentrated Liquid Human Milk Fortifier

In one suitable use, the pouch 10, 110, 210 can contain liquid humanmilk fortifier capable of being poured directly from the pouch into acontainer having human milk therein. It is understood, however, that thepouch 10, 110, 210 can contain any suitable product including otherproducts intended for human consumption. One suitable liquid human milkfortifier is a concentrated liquid human milk fortifier comprisingprotein, fat, carbohydrate OSA-modified starch and low acyl gellan gum.The concentrated liquid human milk fortifier has a solids content of atleast about 20%, or even at least about 25%, including from about 25% toabout 32%, and further including from about 29% to about 32%. Theconcentrated liquid human milk fortifier has a caloric density of atleast about 1.25 kcal/ml (37 kcal/fl oz), including from about 1.4kcal/ml (42 kcal/fl oz) to about 5 kcal/ml (149 kcal/fl oz), and alsoincluding from about 1.5 kcal/ml (44 kcal/fl oz) to about 2.5 kcal/ml(74 kcal/fl oz), and also including from about 1.9 kcal/ml (56 kcal/floz) to about 2.0 kcal/ml (59 kcal/fl oz). The concentrated liquid humanmilk fortifiers is formulated to provide fortified human milk having anosmolality of less than about 400 mOsm/kg water, preferably from about300 mOsm/kg water to about 400 mOsm/kg water.

Extensively Hydrolyzed Casein Protein

The concentrated liquid human milk fortifier includes hypoallergenicextensively hydrolyzed casein as a protein source. The term“hypoallergenic” as used herein means that the concentrated liquid humanmilk fortifier has a decreased tendency to provoke an allergic reactionin a preterm or term infant as compared to non-hypoallergenicfortifiers. Generally, the concentrated liquid human milk fortifierincludes at least about 35%, including at least about 50%, including atleast about 60%, including at least about 75%, including at least about90% and further including about 100% extensively hydrolyzed casein, bytotal weight of protein in the concentrated human milk fortifier. In oneembodiment, the concentrated liquid human milk fortifier includes 100%extensively hydrolyzed casein, by total weight of the protein in theconcentrated human milk fortifier. In this embodiment, the concentratedliquid human milk fortifier is hypoallergenic. In some otherembodiments, the concentrated liquid human milk fortifier will includefrom about 35% to 100%, including from about 50% to 100%, furtherincluding from about 75% to 100% extensively hydrolyzed casein, by totalweight of protein in the concentrated human milk fortifier. Theconcentrated liquid human milk fortifier may optionally include otherhypoallergenic or non-hypoallergenic proteins in addition to theextensively hydrolyzed casein protein.

Extensively hydrolyzed casein proteins suitable for use in concentratedliquid human milk fortifiers include those having a degree of hydrolysisof from about 20% to about 70%, including from about 30% to about 60%,and further including from about 40% to about 60%. Generally, theextensively hydrolyzed casein has a ratio of total amino nitrogen (AN)to total nitrogen (TN) of from about 0.2 AN to 1.0 TN to about 0.4 AN toabout 0.8 TN. Suitable commercially available extensively hydrolyzedcaseins will generally have a protein level in the ingredient of fromabout 50% to about 95%, including from about 70% to about 90%. Onesuitable commercially available extensively hydrolyzed casein is DellacCE90, which is a spray dried powder casein hydrolysate (FrieslandCampina Domo, Amersfoort, The Netherlands).

Stabilizer System

The concentrated liquid human milk fortifier includes a synergistic twocomponent stabilizer system. The first component is an octenyl succinicanhydride (OSA) modified corn starch. The second component is a low acylgellan gum. These two components act in a synergistic manner tostabilize the concentrated liquid human milk fortifier emulsion andretard the precipitation of nutrients therefrom.

The OSA-modified corn starch is generally prepared by esterifying adextrinized, ungelatinized waxy corn starch with 1-octenyl succinicanhydride. Methods of this type are well known in the art. One suitablecommercially available OSA-modified corn starch is N-CREAMER™ 46(National Starch Food Innovation, Bridgewater, N.J.). Without beingbound to a particular theory, it is believed that the OSA-modified cornstarch adsorbs in the oil and water interface thus preventing the oildroplets from coalescence/aggregation by steric hinderance and chargerepulsion. The OSA-modified corn starch is present in the concentratedliquid human milk fortifier in an amount of from about 0.1% to about3.5%, including from about 0.6% to about 2.0%, including from about 0.8%to about 1.5%, and further including about 1.2% by weight of theconcentrated liquid human milk fortifier.

The low acyl gellan gum (also known as and commonly referred to asdeacylated gellan gum) may be a water-soluble polysaccharide produced byfermentation of a pure culture of Sphingomonas elodea. As used herein,“low acyl” means that the gellan gum has been treated such that it formsfirm, non-elastic, brittle gels, that are heat stable, as compared to“high acyl” which forms soft, very elastic, non-brittle gels. Withoutbeing bound to a particular theory, it is believed that the low acylgellan gum creates a three dimensional gelled network of very smallmicrogels that interact with each other to provide a stable suspension.One suitable commercially available low acyl gellan gum is Kelcogel F(CP Kelco U.S. Inc., Atlanta Ga.).

The low acyl gellan gum is present in the concentrated liquid human milkfortifier in an amount from greater than 125 ppm to about 800 ppm,including from about 150 ppm to about 400 ppm, including from about 200ppm to about 300 ppm and further including about 200 ppm.

Macronutrients

The concentrated liquid human milk fortifier comprises carbohydrate,fat, and protein macronutrients of sufficient types and amounts, thatwhen used in combination with human milk (or other infant feedingformula), they help meet the nutritional needs of infants and especiallypremature infants. The concentration of these macronutrients includesthe ranges described hereinafter. The term “infant” as used herein,refers generally to individuals less than about 1 year of age, actual orcorrected. The term “premature infants” are used herein refers to thoseinfants born at less than 37 weeks gestation, have a birth weight ofless than 2500 gm, or both.

Protein

The concentrated liquid human milk fortifier comprises a proteinsuitable for use with infants, especially preterm infants, atconcentrations ranging from about 5% to about 50%, including from about20% to about 40%, including from about 5% to about 30%, including fromabout 10% to about 25%, and also including from about 15% to about 25%,on a dry weight basis. In some embodiments, the protein may be at aconcentration of less than 10%, on a dry weight basis. The proteinconcentration may be from about 7 to about 15 grams, including fromabout 9 to about 12 grams of protein per 100 grams of final liquidproduct.

As noted above, the protein component of the concentrated liquid humanmilk fortifier is at least partially comprised of extensively hydrolyzedcasein. In one particularly suitable embodiment, the protein componentof the concentrated human milk fortifier is entirely comprised ofextensively hydrolyzed casein. In embodiments wherein additionalproteins sources (i.e., one or more protein sources in addition to theextensively hydrolyzed protein source) are to be used in theconcentrated liquid human milk fortifier in addition to the extensivelyhydrolyzed casein (i.e., the concentrated human milk fortifier proteincomponent is not 100% extensively hydrolyzed casein), the fortifier maystill be made hypoallergenic by including additional hypoallergenicproteins such as soy protein hydrolysate, whey protein hydrolysate, riceprotein hydrolysate, potato protein hydrolysate, fish proteinhydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate,combinations of animal and vegetable protein hydrolysates, andcombinations thereof.

In this context, the terms “protein hydrolysates” or “hydrolyzedprotein” are used interchangeably herein and include extensivelyhydrolyzed proteins, wherein the degree of hydrolysis is most often atleast about 20%, including from about 20% to about 80%, and alsoincluding from about 30% to about 80%, even more preferably from about40% to about 60%. The degree of hydrolysis is the extent to whichpeptide bonds are broken by a hydrolysis method. The degree of proteinhydrolysis for purposes of characterizing the extensively hydrolyzedprotein component of these embodiments is easily determined by one ofordinary skill in the formulation arts by quantifying the amino nitrogento total nitrogen ratio (AN/TN) of the protein component of the selectedformulation. The amino nitrogen component is quantified by USP titrationmethods for determining amino nitrogen content, while the total nitrogencomponent is determined by the Tecator Kjeldahl method, all of which arewell known methods to one of ordinary skill in the analytical chemistryart.

In other embodiments, the concentrated liquid human milk fortifier, inaddition to the extensively hydrolyzed protein, may include anadditional non-hypoallergenic protein source including for example,partially hydrolyzed or non-hydrolyzed (intact) protein, and can bederived from any known or otherwise suitable source such as milk (e.g.,casein, whey, lactose-free milk protein isolates), animal (e.g., meat,fish), cereal (e.g., rice, corn), vegetable (e.g., soy), or combinationsthereof. The protein can include, or be entirely or partially replacedby, free amino acids known or otherwise suitable for use in nutritionalproducts, non-limiting examples of which include free amino acidsincluding L-alanine, L-arginine, L-asparagine, L-aspartic acid,L-carnitine, L-cystine, L-glutamic acid, L-glutamine, glycine,L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine,L-phenylalanine, L-proline, L-serine, L-taurine, L-threonine,L-tryptophan, L-tyrosine, L-valine, and combinations thereof.

Carbohydrate

The concentrated liquid human milk fortifier comprises a carbohydratesuitable for use with infants, especially preterm infants, atconcentrations most typically ranging up to about 75% by weight on a dryweight basis, including from about 10% to about 50%, and also includingfrom about 20% to about 40%, by weight on a dry weight basis.Carbohydrates suitable for use in the concentrated liquid human milkfortifier include hydrolyzed or intact, naturally and/or chemicallymodified, starches sourced from corn, tapioca, rice or potato, in waxyor non-waxy forms. Other non-limiting examples of suitable carbohydratesources include hydrolyzed cornstarch, maltodextrin (i.e. non-sweet,nutritive polysaccharide having a DE value less than 20), cornmaltodextrin, glucose polymers, sucrose, corn syrup, corn syrup solids(i.e., polysaccharide having a DE value greater than 20), glucose, ricesyrup, fructose, high fructose corn syrup, indigestible oligosaccharidessuch as fructooligosaccharides (FOS), galactose, glycerol andcombinations thereof. The carbohydrates may comprise lactose or can besubstantially free of lactose.

The concentrated liquid human milk fortifier may include a non-reducingcarbohydrate component, which may represent from about 10% to 100%,including from about 80% to 100%, and also including 100%, by weight ofthe total carbohydrate in the concentrated liquid human milk fortifier.The selection of a non-reducing carbohydrate may enhance the productstability and is generally better tolerated by infants, especiallypremature infants. Non-limiting examples of non-reducing carbohydratesinclude sucrose or other carbohydrates that do not readily oxidize orreact with Tollen's, Benedict's, or Fehling's reagents. The concentratedliquid human milk fortifier may have a carbohydrate component, whereinthe carbohydrate component comprises a mono- and/or disaccharide suchthat at least about 50%, including from about 80% to 100%, and alsoincluding 100%, of the mono- and/or disaccharide is a non-reducingcarbohydrate.

Fat

The concentrated liquid human milk fortifier comprises a fat componentsuitable for use with infants, especially preterm infants, atconcentrations most typically ranging up to about 40% by weight on a dryweight basis, including from about 10% to about 40%, and also includingfrom about 15% to about 37%, and also including from about 18% to about30%, by weight on a dry weight basis. Fats suitable for use in theconcentrated liquid human milk fortifier include coconut oil, soy oil,corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil(medium chain triglycerides), sunflower oil, high oleic sunflower oil,structured triglycerides, palm and palm kernel oils, palm olein, canolaoil, marine oils, cottonseed oils, and combinations thereof.

Suitable fats for use in the concentrated liquid human milk fortifierinclude emulsifiers to help the various fortifier components readilydisperse when combined with human milk. Non-limiting examples ofsuitable emulsifiers include soya bean lecithin, or fractions there of,polyoxyethylene stearate, mono and di-glycerides, and combinations thereof, polyoxyethylene sorbitan monopalmitate, polyoxyethylene sorbitanmonostearate, ammonium phosphatides, polyoxyethylene sorbitanmonolaurate, citric acid esters of mono and diglycerides of fatty acids,tartaric acid esters of mono and diglycerides of fatty acids, andcombinations thereof. Natural soy lecithin is especially useful in thisrespect. The fat component of the concentrated liquid human milkfortifier may therefore optionally include any emulsifier suitable foruse in infant nutritional products. Emulsifier concentrations in theseproducts may range up to about 10%, including from about 1% to about10%, even more typically from about 1.5% to about 5%, by weight of thetotal fat component.

The concentrated liquid human milk fortifier also include embodimentsthat comprise as part of the fat component one or more of arachidonicacid, docosahexaenoic acid, or combinations thereof, alone or in furthercombination with linoleic acid, linolenic acid, or both.

The weight ratio of fat to protein in the concentrated liquid human milkfortifier is at least about 0.9, including from about 1 to about 5, andalso including from about 2 to about 4. These ratios may be helpful infurther stabilizing the concentrated liquid human milk fortifier.

Vitamins and Minerals

The concentrated liquid human milk fortifier may further comprise any ofa variety of vitamins, non-limiting examples of which include vitamin A,vitamin D, vitamin E, vitamin K, thiamine, riboflavin, pyridoxine,vitamin B12, niacin, folic acid, pantothenic acid, biotin, vitamin C,choline, inositol, salts and derivatives thereof, and combinationsthereof. The concentrated liquid human milk fortifier includesembodiments comprising per 100 kcal of fortifier solids one or more ofthe following: vitamin A (from about 250 to about 6500 IU), vitamin D(from about 40 to about 1200 IU), vitamin K, vitamin E (at least about0.3 IU), vitamin C (at least about 8 mg), thiamine, vitamin B12, niacin,folic acid, pantothenic acid, biotin, choline (at least about 7 mg), andinositol (at least about 2 mg).

The concentrated liquid human milk fortifiers may also further compriseany of a variety of minerals known or otherwise suitable for use ininfant or other nutritional formulas, non-limiting examples of whichinclude phosphorus, magnesium, calcium as described hereinbefore, zinc,manganese, copper, iodine, sodium, potassium, chloride, selenium,chromium, and combinations thereof. The concentrated liquid human milkfortifier also includes embodiments comprising per 100 kcal of thefortifier solids one or more of the following: calcium (at least about50 mg), phosphorus (at least about 25 mg), magnesium (at least about 6mg), iodine, zinc (at least about 0.5 mg), copper, manganese, sodium(from about 20 to about 60 mg), potassium (from about 80 to about 200mg), chloride (from about 55 to about 150 mg) and selenium (at leastabout 0.5 mcg).

Other Optional Ingredients

The concentrated liquid human milk fortifier may further optionallycomprise other ingredients that may modify the physical, chemical,aesthetic or processing characteristics of the formulas or serve aspharmaceutical or additional nutritional components when used in thetargeted population. Many such optional ingredients are known for use infood and nutritional products, including infant formulas, and may alsobe used in the concentrated liquid human milk fortifiers, provided thatsuch optional materials are compatible with the essential materialsdescribed herein, are safe and effective for their intended use, and donot otherwise unduly impair the performance of the concentrated liquidhuman milk fortifier. Non-limiting examples of such optional ingredientsinclude preservatives, anti-oxidants, various pharmaceuticals, buffers,carotenoids, colorants, flavors, nucleotides and nucleosides, thickeningagents, prebiotics, probiotics, sialic acid-containing materials, andother excipients or processing aids.

Examples Examples 1-4

The ingredients for the concentrated liquid human milk fortifiers ofExamples 1-4 are shown in the following table.

Ingredient (Per 1000 Kg) Example 1 Example 2 Example 3 Example 4 WaterQ.S. Q.S. Q.S. Q.S. Casein Hydrolysate 108 Kg 108 Kg 125 Kg 150 KgMaltodextrin 104 Kg 104 Kg 104 Kg 104 Kg MCT Oil 17.3 Kg 17.3 Kg 17.3 Kg17.3 Kg Tricalcium Phosphate 16.0 Kg 16.0 Kg 16.0 Kg 16.0 Kg Soy Oil10.4 Kg 10.4 Kg 10.4 Kg 10.4 Kg OSA-Modified 12.0 Kg 10.0 Kg 35.0 Kg 6.0Kg Corn Starch Coconut Oil 6.3 Kg 6.3 Kg 6.3 Kg 6.3 Kg Potassium Citrate6.9 Kg 6.9 Kg 6.9 Kg 6.9 Kg Ascorbic Acid 2.9 Kg 2.9 Kg 2.9 Kg 2.9 KgMagnesium Chloride 4.0 Kg 4.0 Kg 4.0 Kg 4.0 Kg M. Alpina Oil (ARA) 2.6Kg 2.6 Kg 2.6 Kg 2.6 Kg Leucine 1.8 Kg 1.8 Kg 1.8 Kg 1.8 Kg C. CohniiOil (DHA) 2.1 Kg 2.1 Kg 2.1 Kg 2.1 Kg Potassium Chloride 1.1 Kg 1.1 Kg1.1 Kg 1.1 Kg Tyrosine 1.4 Kg 1.4 Kg 1.4 Kg 1.4 Kg DistilledMonoglycerides 800 g 800 g 800 g 800 g Mixed Carotenoid 551 g 551 g 551g 551 g Premix M-Inositol 529 g 529 g 529 g 529 g Sodium Chloride 861 g861 g 861 g 861 g L-Carnitine 221 g 221 g 221 g 221 g Tryptophan 331 g331 g 331 g 331 g Zinc Sulfate 309 g 309 g 309 g 309 g Niacinamide 320 g320 g 320 g 320 g dl-Alpha-Tocopheryl 364 g 364 g 364 g 364 g AcetateGellan gum 200 g 300 g 400 g 600 g Ferrous Sulfate 106 g 106 g 106 g 106g Choline Chloride 353 g 353 g 353 g 353 g Calcium Pantothenate 132 g132 g 132 g 132 g Vitamin A Palmitate 77 g 77 g 77 g 77 g Riboflavin 33g 33 g 33 g 33 g Vitamin D3 13 g 13 g 13 g 13 g Copper Sulfate 18 g 18 g18 g 18 g Pyridoxine 20 g 20 g 20 g 20 g Hydrochloride ThiaminHydrochloride 24 g 24 g 24 g 24 g Folic Acid 3.3 g 3.3 g 3.3 g 3.3 gBiotin 2.5 g 2.5 g 2.5 g 2.5 g Manganese Sulfate 1.8 g 1.8 g 1.8 g 1.8 gPhylloquinone 880 mg 880 mg 880 mg 880 mg Sodium Selenate 90 mg 90 mg 90mg 90 mg Cyanocobalamin 88 mg 88 mg 88 mg 88 mg Potassium Hydroxide Q.S.Q.S. Q.S. Q.S.

The concentrated liquid human milk fortifier is prepared by solubilizingand combining/mixing ingredients into a homogeneous aqueous mixturewhich is subjected to a sufficient thermal treatment and aseptic fillingto achieve long term physical and microbial shelf stability. The term“shelf stability” as used herein means that the concentrated liquidhuman milk fortifier is resistant to separation and precipitation fortime period after manufacture of at least three months, and preferablyat least six months.

To begin the manufacturing process, macronutrients (carbohydrate,protein, fat, and minerals) are combined in several slurries togetherand with water. This blend is subjected to an initial heat treatment andthen tested to verify proper nutrient levels. An intermediate aqueouscarbohydrate-mineral (CHO-MIN) slurry is prepared by heating appropriateamount of water to 140-160° F. With agitation, the following solubleingredients are added: maltodextrin, potassium citrate, magnesiumchloride, potassium chloride, sodium chloride, and choline chloride. Thecarbohydrate-mineral slurry is held at 130-150° F. under agitation untiladded to the blend.

An intermediate oil slurry is prepared by heating MCT oil and coconutoil to 150 to 170° C. and then adding distilled monoglycerides withagitation for a minimum of 10 minutes in order to the ingredient todissolve. Soy oil, vitamin A palmitate, vitamin D3,di-alpha-tocopheryl-acetate, phylloquinone, ARA-containing oil,DHA-containing oil, and carotenoid premix are then added with agitationto the oil blend. Insoluble mineral calcium source, and ultra micronizedtricalcium phosphate is added to the oil. Gellan gum and OSA-modifiedstarch are then added to the oil blend with proper agitation. The oilblend slurry is maintained at 130-150° F. under agitation until added tothe blend.

The blend is prepared by combining the ingredient water, caseinhydrolysate, all of the CHO-MIN slurry and whole oil blend slurry. Theblend is maintained at 120° F. for a period of time not to exceed twohours before further processing.

The blend is then homogenized using one or more in-line homogenizers atpressures from 1000-4000 psig with or without a second stagehomogenization from 100-500 psig followed by heat treatment using aUHTST (ultra-high temperature short time, 292-297° F. for 5-15 seconds)process. After the appropriate heat treatment, the batch is cooled in aplate cooler to 33-45° F. and then transferred to a refrigerated holdingtank, where it is subjected to analytical testing.

The next step in the manufacturing process involves adding vitamins,trace minerals, other ingredients, and water in order to reach the finaltarget total solids and vitamin/mineral contents. The final batch isfilled into a suitable container under aseptic conditions or treatedwith a terminal sterilization process so the product will be stable atroom temperature for an extended shelf-life. Additional detail on thisprocess is provided in the following paragraphs.

A trace mineral/vitamin/nutrient solution (STD1) is prepared by heatingwater to 80-100° F. and adding the following ingredients with agitation:potassium citrate, ferrous sulfate, zinc sulfate, copper sulfate,manganese sulfate, sodium selenate, pyridoxine hydrochloride,riboflavin, thiamine hydrochloride, cyanocobalamin, folic acid, calciumpantothenate, niacinamide, biotin, m-inositol, nucleotide/cholinepremix, L-carnitine, L-Leucine, and L-tyrosine.

A vitamin C solution (STD2) is prepared by adding ascorbic acid to awater solution with agitation.

All STD1 and STD2 solutions are then added to the refrigerated batch,with agitation. The appropriate amount of ingredient dilution water isthen added to the batch to achieve a target total solids level of29.0-32.0%. The final batch is then subjected to appropriate thermaltreatment and filled into a suitable container (e.g., pouches 10, 110,120) under aseptic packaging conditions and processes. The term “asepticpackaging” as used herein, unless otherwise specified, refers to themanufacture of a packaged product without reliance upon “retortpackaging”, wherein the nutritional liquid and package are sterilizedseparately prior to filling, and then are combined under sterilized oraseptic processing conditions to form a sterilized, asepticallypackaged, nutritional liquid product. The term “retort packaging” asused herein, and unless otherwise specified, refers to the commonpractice of filling a container, most typically a metal can or othersimilar package, with a nutritional liquid and then subjecting theliquid-filled package to the necessary heat sterilization step, to forma sterilized, retort packaged, nutritional liquid product.

Example 5

In Example 5, four separate concentrated liquid human milk fortifierswere prepared and the overall stability in terms of amount of phaseseparation (emulsion stability), sediment at the bottom of thecontainer, and creaming at the top of the liquid, of each was evaluatedat 24 hours after manufacture. Each of the four tested concentratedliquid human milk fortifiers was based on the concentrated liquid humanmilk fortifier of Example 2 above.

The first concentrated liquid human milk fortifier was identical to thatof Example 2 except that it did not contain any OSA-modified corn starchand did not contain any low acyl gellan gum. The second fortifier wasidentical to that of Example 2 except that it did not contain any lowacyl gellan gum. The third fortifier was identical to that of Example 2except that it did not contain any OSA-modified corn starch. The fourthfortifier was identical to that of Example 2. Each of the fourfortifiers was prepared in accordance with the manufacturing process ofExamples 1-4.

Upon evaluation, the first fortifier (no OSA-modified corn starch and nolow acyl gellan gum) showed nearly complete phase separation of the oiland water phases, and showed both heavy creaming at the top of theliquid and heavy sediment at the bottom of the container. See FIG. 22.

Upon evaluation, the second fortifier (no low acyl gellan gum) showedboth heavy creaming at the top of the liquid and heavy sediment at thebottom of the container. See FIG. 23.

Upon evaluation, the third fortifier (no OSA-modified corn starch)showed nearly complete phase separation of the oil phase and the waterphase. See FIG. 24.

Upon evaluation, the fourth fortifier (containing both OSA-modified cornstarch and low acyl gellan gum) showed no phase separation, no creaming,and no sediment. See FIG. 25. The stabilizing system of a combination ofOSA-modified corn starch and low acyl gellan gum showed a synergisticinteraction and allowed for the manufacture of physically stableconcentrated liquid human milk fortifier containing extensivelyhydrolyzed casein and a high level of insoluble calcium salts withoutcausing defects in emulsion stability and sediment fall out.

Gelled Human Milk Fortifier

Another suitable human milk fortifier suitable for packaging in thepouches 10, 110, 210 is a gelled human milk fortifier. The gelled humanmilk fortifier generally comprises protein, fat, and carbohydrate in astable, concentrated gel that is shear thinning and stabilizer-free. Theterm “gelled human milk fortifier” as used herein means a human milkfortifier that is in the form of a colloid in which the dispersed phasehas combined with the dispersion medium to produce a semisolid material,such as a jelly, pudding or yogurt. A “gelled human milk fortifier” hasa viscosity at room temperature of greater than 800, 900 or even 1000cps as measured using a Brookfield Viscometer (spindle 61, 60 rpm, after10 seconds of rotation). The term “shear thinning” as used herein meansan effect where viscosity decreases with increasing rate of shearstress.

Various embodiments of the gelled human milk fortifiers can besubstantially free of any optional or selected essential ingredient orfeature described herein, provided that the remaining gelled human milkfortifier still contains all of the required ingredients or features asdescribed herein. In this context, and unless otherwise specified, theterm “substantially free” means that the selected gelled human milkfortifier contains less than a functional amount of the optionalingredient, typically less than 0.1% by weight, and also including zeropercent by weight of such optional or selected essential ingredient. Thegelled human milk fortifiers can comprise, consist of, or consistessentially of the essential elements, as well as any additional oroptional ingredients, components, or limitations described herein orotherwise useful in the gelled human milk fortifier.

Product Form

The gelled human milk fortifier is shear thinning such that they caneasily be converted from the gelled form to a liquid form by shakingand/or kneading prior to being poured from the pouch 10, 110, 210.Generally, the gelled human milk fortifier has a viscosity of greaterthan 1000 cps at room temperature as measured using a BrookfieldViscometer Model DVII (spindle 61, 60 rpm, after 10 seconds rotation).The gelled human milk fortifier has a shaken viscosity, as definedherein, of from about 20 cps to about 200 cps, or even from about 20 cpsto about 150 cps, or even from about 20 cps to about 100 cps, or evenfrom about 20 cps to about 80 cps, or even from about 50 cps to about 95cps. Generally, as the gelled human milk fortifier ages, the shakenviscosity will increase slightly.

The gelled human milk fortifier has a gel strength, as defined herein,of from about 25 grams to about 200 grams, or even from about 50 gramsto about 200 grams, or even from about 75 grams to about 150 grams. Thegelled human milk fortifier has a shaken gel strength of less than 10,or even less than 5 or even zero. In one suitable embodiment, the shakengel strength is zero.

The gelled human milk fortifiers can be stabilizer free. That is, theymay be formulated to not include any stabilization agent for keepingprecipitation and/or settling from occurring in the fortifier. Byformulating the gelled human milk fortifier to be stabilizer free, itbecomes more acceptable worldwide. Specifically, the gelled human milkfortifier can be formulated to be carrageenan-free.

The gelled human milk fortifier is generally formulated to have acaloric density of at least about 1.25 kcal/ml (37 kcal/fl oz),including from about 1.4 kcal/ml (42 kcal/fl oz) to about 5 kcal/ml (149kcal/fl oz), and also including from about 1.5 kcal/ml (44 kcal/fl oz)to about 2.5 kcal/ml (74 kcal/fl oz), and also including from about 1.9kcal/ml (56 kcal/fl oz) to about 2.0 kcal/ml (59 kcal/fl oz). The gelledhuman milk fortifier is preferably formulated to provide fortified humanmilk having an osmolality of less than about 400 mOsm/kg water,preferably from about 300 mOsm/kg water to about 400 mOsm/kg water.

Macronutrients

The gelled human milk fortifiers of the present disclosure comprisecarbohydrate, fat, and protein macronutrients of sufficient types andamounts, that when used in combination with human milk or other infantfeeding formula, they help meet the nutritional needs of the infant,especially the premature infant. The concentration of thesemacronutrients in the various embodiments of the present disclosureincludes the ranges described hereinafter.

Protein

The gelled human milk fortifier comprises a protein suitable for usewith infants, especially preterm infants, at concentrations ranging fromabout 10% to about 30%, including from about 10% to about 25%, and alsoincluding from about 15% to about 25%, on a dry weight basis. In someembodiments, the protein may be at a concentration of less than 10%.

In one suitable embodiment, the gelled human milk fortifier is preparedby aseptic processing, which comprise the requisite proteinconcentrations with a specific blend of casein and whey protein. Theblend includes from about 40% to about 80% by weight of whey protein,including from about 50% to about 70% by weight whey protein, includingfrom about 55% to about 70% by weight whey protein, and including fromabout 60% to about 70% by weight whey protein, in combination with fromabout 20% to about 60% by weight of casein protein, including from about30% to about 50% by weight of casein protein, including from about 20%to about 50% by weight casein protein, including from about 20% to about45% by weight casein protein, including from about 20% to about 40% byweight casein protein, including from about 20% to about 30% caseinprotein. It has been found that these particular blends of whey proteinand casein protein provide for a suitable gelled human milk fortifierthat can be prepared by aseptic processing.

In some embodiments, in addition to the whey protein and casein proteinoutlined above, the gelled human milk fortifier may contain additionalprotein. Suitable additional protein may include soy proteinhydrolysate, casein protein hydrolysate, whey protein hydrolysate, riceprotein hydrolysate, potato protein hydrolysate, fish proteinhydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate,combinations of animal and vegetable protein hydrolysates, andcombinations thereof.

Proteins suitable for use in the gelled human milk fortifier may includeintact or hydrolyzed proteins, free amino acids, or combinationsthereof. Non-limiting examples of suitable proteins include hydrolyzed,partially hydrolyzed or non-hydrolyzed protein, and can be derived fromany known or otherwise suitable source such as milk (e.g., casein, whey,lactose-free milk protein isolates), animal (e.g., meat, fish), cereal(e.g., rice, corn), vegetable (e.g., soy), or combinations thereof. Theprotein can include, or be entirely or partially replaced by, free aminoacids known or otherwise suitable for use in nutritional products,non-limiting examples include L-alanine, L-arginine, L-asparagine,L-aspartic acid, L-carnitine, L-cystine, L-glutamic acid, L-glutamine,glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine,L-phenylalanine, L-proline, L-serine, L-taurine, L-threonine,L-tryptophan, L-tyrosine, L-valine, and combinations thereof.

Carbohydrate

The gelled human milk fortifiers comprises a carbohydrate suitable foruse with infants, especially preterm infants, at concentrations mosttypically ranging up to about 75% by weight on a dry weight basis,including from about 10% to about 50%, and also including from about 20%to about 40%, by weight on a dry weight basis. Carbohydrates suitablefor use in the gelled human milk fortifiers include hydrolyzed orintact, naturally and/or chemically modified, starches sourced fromcorn, tapioca, rice or potato, in waxy or non-waxy forms. Othernon-limiting examples of suitable carbohydrate sources includehydrolyzed cornstarch, maltodextrin (i.e. non-sweet, nutritivepolysaccharide having a DE value less than 20), corn maltodextrin,glucose polymers, sucrose, corn syrup, corn syrup solids (i.e.,polysaccharide having a DE value greater than 20), glucose, rice syrup,fructose, high fructose corn syrup, indigestible oligosaccharides suchas fructooligosaccharides (FOS), and combinations thereof. Thecarbohydrates may comprise lactose or can be substantially free oflactose.

One embodiment of the gelled human milk fortifier includes anon-reducing carbohydrate component, which may represent from about 10%to 100%, including from about 80% to 100%, and also including 100%, byweight of the total carbohydrate. The selection of a non-reducingcarbohydrate may enhance the product stability and is generally bettertolerated by infants, especially premature infants. Non-limitingexamples of non-reducing carbohydrates include sucrose or othercarbohydrates that do not readily oxidize or react with Tollen's,Benedict's, or Fehling's reagents. The gelled human milk fortifiertherefore includes embodiments comprising a carbohydrate component,wherein the carbohydrate component comprises a mono- and/or disaccharidesuch that at least about 50%, including from about 80% to 100%, and alsoincluding 100%, of the mono- and/or disaccharide is a non-reducingcarbohydrate.

Fat

The gelled human milk fortifiers also comprises a fat component suitablefor use with infants, especially preterm infants, at concentrations mosttypically ranging up to about 40% by weight on a dry weight basis,including from about 10% to about 40%, and also including from about 15%to about 37%, and also including from about 18% to about 30%, by weighton a dry weight basis. Fats suitable for use in the gelled human milkfortifier may include coconut oil, soy oil, corn oil, olive oil,safflower oil, high oleic safflower oil, MCT oil (medium chaintriglycerides), sunflower oil, high oleic sunflower oil, structuredtriglycerides, palm and palm kernel oils, palm olein, canola oil, marineoils, cottonseed oils, and combinations thereof.

Suitable fats for use in the gelled human milk fortifier includeemulsifiers to help the various fortifier components readily dispersewhen combined with human milk. Non-limiting examples of suitableemulsifiers include soya bean lecithin, polyoxythylene stearate,polyoxyethylene sorbitan mono-oleate, polyoxyethylene sorbitanmonopalmitate, polyoxyethylene sorbitan monostearate, ammoniumphosphatides, polyoxyethylene sorbitan monolaurate, citric acid estersof mono and diglycerides of fatty acids, tartaric acid esters of monoand diglycerides of fatty acids, and combinations thereof. Natural soylecithin is especially useful in this respect. The fat component of thegelled human milk fortifier may therefore optionally include anyemulsifier suitable for use in infant nutritional products. Emulsifierconcentrations in these products may range up to about 10%, includingfrom about 1% to about 10%, even more typically from about 1.5% to about5%, by weight of the total fat component. The weight ratio of fat toprotein (fat:protein, by weight) in the human milk fortifier is at leastabout 0.9, including from about 1 to about 5, and also including fromabout 2 to about 4. These ratios may be helpful in further stabilizingthe gelled human milk fortifier.

The gelled human milk fortifier also include embodiments that comprise,as part of the fat component, one or more of arachidonic acid,docosahexaenoic acid, or combinations thereof, alone or in furthercombination with linoleic acid, linolenic acid, or both.

Vitamins and Minerals

The gelled human milk fortifier may further comprise any of a variety ofvitamins, non-limiting examples of which include vitamin A, vitamin D,vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12,niacin, folic acid, pantothenic acid, biotin, vitamin C, choline,inositol, salts and derivatives thereof, and combinations thereof. Thegelled human milk fortifier includes embodiments comprising per 100 kcalof fortifier solids one or more of the following: vitamin A (from about250 to about 750 IU), vitamin D (from about 40 to about 100 IU), vitaminK, vitamin E (at least about 0.3 IU), vitamin C (at least about 8 mg),thiamine, vitamin B12, niacin, folic acid, pantothenic acid, biotin,choline (at least about 7 mg), and inositol (at least about 2 mg).

The gelled human milk fortifier may also further comprise any of avariety of minerals known or otherwise suitable for use in infant orother nutritional formulas, non-limiting examples of which includephosphorus, magnesium, calcium as described hereinbefore, zinc,manganese, copper, iodine, sodium, potassium, chloride, selenium, andcombinations thereof. The gelled human milk fortifier also includeembodiments comprising per 100 kcal of the fortifier solids one or moreof the following: calcium (at least about 50 mg), phosphorus (at leastabout 25 mg), magnesium (at least about 6 mg), iodine, zinc (at leastabout 0.5 mg), copper, manganese, sodium (from about 20 to about 60 mg),potassium (from about 80 to about 200 mg), chloride (from about 55 toabout 150 mg) and selenium (at least about 0.5 mcg).

Other Optional Ingredients

The gelled human milk fortifier may further optionally comprise otheringredients that may modify the physical, chemical, aesthetic orprocessing characteristics of the formulas or serve as pharmaceutical oradditional nutritional components when used in the targeted population.Many such optional ingredients are known for use in food and nutritionalproducts, including infant formulas, and may also be used in the gelledhuman milk fortifiers of the present disclosure, provided that suchoptional materials are compatible with the essential materials describedherein, are safe and effective for their intended use, and do nototherwise unduly impair product performance. Non-limiting examples ofsuch optional ingredients include preservatives, anti-oxidants, variouspharmaceuticals, buffers, carotenoids, colorants, flavors, nucleotidesand nucleosides, thickening agents, prebiotics, probiotics, sialicacid-containing materials, and other excipients or processing aids.

EXAMPLES

The following examples illustrate specific embodiments and/or featuresof the gelled human milk fortifier. The examples are given solely forthe purpose of illustration as many variations thereof are possible. Allexemplified amounts are weight percentages based upon the total weightof the formulation, unless otherwise specified.

Example 1

In this Example, a gelled human milk fortifier is prepared with theingredients shown in the following table.

Qty. per Ingredients 32000 lb Water Q.S. Condensed Skim Milk 5250 KgNon-Fat Milk Solids 1365 Kg Corn Maltodextrin 1450 Kg Corn Syrup Solids1388 Kg Medium Chain triglycerides 694 Kg Whey Protein Concentrate 634Kg Calcium Phosphate 271 Kg Ascorbic Acid 152 Kg Magnesium Chloride 38.0Kg Potassium Citrate 12.2 Kg Sodium Chloride 12.1 Kg Soy Lecithin 8.84Kg M-Inositol 7.98 Kg Magnesium Phosphate 5.55 Kg M. Alpina Oil 5.35 KgNiacinamide 4.35 Kg Alpha-Tocopheryl Acetate 4.21 Kg Zinc Sulfate 3.51Kg C. Cohnii Oil 3.45 Kg Choline Chloride 2.90 Kg Calcium Pantothenate1.89 Kg Potassium Phosphate 1.62 Kg Ferrous Sulfate 1.64 Kg Vitamin APalmitate 900 g Cupric Sulfate 678 g Riboflavin 572 g ThiamineHydrochloride 373 g Pyridoxine Hydrochloride 232 g Vitamin D3 152 gFolic Acid 47.9 g Biotin 34.1 g Manganese Sulfate 23.2 g Phylloquinone11.6 g Cyanocobalamin 1.60 g Sodium Selenate 0.798 g Calcium Carbonateas needed Sodium Citrate as needed Potassium Hydroxide as needed

The gelled human milk fortifier is prepared by solubilizing andcombining ingredients into a homogeneous aqueous mixture which issubjected to an adequate heat treatment to achieve long term shelfstability. To begin the manufacturing process, the ingredients thatsupply the macronutrients (carbohydrate, protein, fat and minerals) arecombined in multiple slurries together and with water. This blend issubjected to an initial heat treatment and then tested to verify propernutrient levels. Additional detail on this process is provided in thefollowing paragraphs.

An intermediate aqueous carbohydrate-mineral slurry is prepared byheating water to 60-66° C. With agitation, the following solubleminerals are added: magnesium chloride, potassium citrate, sodiumchloride, monopotassium phosphate and magnesium phosphate. Once fullydissolved, corn maltodextrin and corn syrup solids are added to themineral solution. The carbohydrate-mineral slurry is held at 54° C.under low agitation until added to the blend.

An intermediate oil and protein slurry is prepared by heating MCT oil to32-43° C. and then adding DHA oil and AA oil, with agitation. A soylecithin emulsifier (8.84 kg) is added with agitation to the heated oilsand allowed to dissolve. Vitamin A, vitamin D, and vitamin K, andnatural vitamin E are then added with agitation to the oil blend. Wheyprotein concentrate and tricalcium phosphate are added to the oil. Theoil and protein slurry is maintained at 38° C. under low agitation untiladded to the blend.

An intermediate aqueous protein slurry is prepared by heating ingredientwater to 49-54° C., and then adding whey protein concentrate withmoderate agitation. The aqueous protein slurry is held at 52° C. underlow agitation until added to the blend.

The blend is prepared by combining the carbohydrate-mineral slurry withcondensed skim milk and non-fat milk solids and then adding the oil andprotein slurry and the aqueous protein slurry. After no less than fiveminutes, the blend pH is adjusted to 6.8-7.0 using a 1N KOH solution,and thereafter maintained at 52-60° C., for a period of time not toexceed two hours before further processing.

The pH adjusted blend is then homogenized using one or more in-linehomogenizers at pressures from 1000-4000 psig with or without a secondstage homogenization from 100-500 psig followed by heat treatment usinga HTST (high temperature short time, 74° C. for 16 seconds). After theappropriate heat treatment, the batch is cooled in a plate cooler to1.0-5.0° C. and then transferred to a refrigerated holding tank, whereit is subjected to analytical testing.

The next step in the manufacturing process involves adding vitamins,trace minerals and water to the target total solids. The final batch issterilized and filled into a suitable container under aseptic conditionsor treated with a terminal sterilization process so the product will bestable at room temperature for an extended shelf life. Additional detailon this process is provided in the following paragraphs.

A trace mineral solution is prepared by heating water to 27-38° C. andadding the following minerals with agitation: potassium citrate, ferroussulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodiumselenate.

A water-soluble vitamin solution is prepared by heating water to 27-38°C. The following vitamins are added to the water with agitation: cholinechloride, niacinamide, riboflavin, calcium pantothenate, pyridoxinehydrochloride, thiamine hydrochloride, m-inositol, biotin, folic acid,and cyanocobalamin.

A vitamin C solution is prepared by adding ascorbic acid to 1N KOHsolution with agitation.

All three vitamin or mineral solutions are then added to therefrigerated batch, with agitation. The appropriate amount of ingredientdilution water is then added to the batch to achieve a target totalsolids level of 32%, and the pH is adjusted to 7.0 with a 1N KOHsolution.

Example 2

In this Example, the unshaken viscosity, shaken viscosity, unshaken getstrength and shaken gel strength of the human milk fortifier prepared inExample 1 is tested at a sample aged three months and a sample aged sixmonths.

The viscosities were measured using a Brookfield Viscometer Model DV11+(spindle 61, 60 rpm, after 10 second of rotation). The gel strengthswere measure using a Stable Micro Systems TA.XT plus Texture Analyzer (1inch ball probe, 20 mm depth). For the shaken samples, each sample wasshaken vigorously by hand for five seconds prior to testing.

The results of the viscosity measurements and gel strengths are shown inthe following Table.

Sample A Sample B (aged 3 months) (aged 6 months) Unshaken ShakenUnshaken Shaken Viscosity >1000 cps 56 cps >1000 cps 95 cps Gel Strength  78 g  0 g  133 g  0 g

As can be seen from the data in the Table, the unshaken viscosities forboth samples are greater than 1000 cps, while the viscosities of bothshaken samples are substantially less (56 cps for 3 months and 95 cpsfor 6 months). This indicates that in unshaken form, a gel is presentwhereas after shear is applied (by shaking) the gel easily breaks forforms a liquid of relatively low viscosity that could easily be pouredfrom one of the pouches 10, 110, 210.

Additionally as can be seen from the data in the Table, the unshaken gelstrength for both samples is relatively high (78 grams at 3 months and133 grams at 6 months), while the gel strengths after shaking for bothsamples is zero grams. This indicates that after shaking, the gel hastransformed into a liquid that could easily be poured from one of thepouches 10, 110, 210.

Dose Pouches

The concentrated liquid human milk fortifier and the gel human milkfortifier can be packaged in suitable unit dose pouches (e.g., pouches10, 110, 210). The term “unit dose” as used herein refers to individual,single-use, pouches of concentrated human milk fortifier containing apredetermined amount of human milk fortifier that can be used in apreparation of a predetermined amount of human milk. The unit dosepouches 10, 110, 210 are single use containers that alone, or incombination with other unit dose pouches, provide sufficient human milkfortifier to supplement human milk for immediate use, e.g., preferablywithin 8-24 hours, more preferably within 0-3 hours, of mixing withhuman milk.

The amount or volume of concentrated liquid human milk fortifier or gelhuman milk fortifier in each unit dose pouch 10, 110, 210 includes thoseembodiments in which the package contains an amount suitable to preparean infant's feeding. In one suitable embodiment, the unit dose pouches10, 110, 210 typically contain sufficient fortifier to provide fromabout 0.5 g to about 10 g of fortifier solids, more typically from about0.8 g to about 5.0 g of fortifier solids, and even more typically fromabout 0.85 g to about 2.0 g, of fortifier solids. The terms “fortifiersolids” or “total solids”, unless otherwise specified, are usedinterchangeably herein and refer to all material components of thecompositions of the present disclosure, less water.

The amount of fortified human milk prepared for a premature infant, forexample, typically ranges from 25 ml to 150 ml a day. Consequently, inone suitable embodiment, a single unit dose is the appropriate amount offortifier solids to fortify a 25 ml preparation. Multiple pouches 10,110, 210 can be used to prepare larger feeding volumes, especially forterm infants.

Aseptic Packaging

The concentrated liquid human milk fortifier and the gel human milkfortifier can be sterilized and aseptically packaged into the pouches10, 110, 210. The aseptic packaging can be accomplished using any of avariety of techniques well known to those of ordinary skill in theformulation art, so long as the technique is sufficient to achieve longterm shelf stability of the fortifier. FIG. 10 is a flow diagram of onesuitable process for manufacturing a plurality of aseptically sterilizedpouches 10, 110, 210 suitable for containing the concentrated liquidhuman milk fortifier, the gel human milk fortifier, or any othersuitable aseptic product. While the following description of the asepticpackaging process is provided with respect to the pouch 10 illustratedin FIGS. 1-6, it is understood that the pouches 110, 210 of FIGS. 8 and9 can be processed in substantially the same manner.

In this embodiment, a web of plastic sheeting (e.g., the two layeredlaminate illustrated in FIG. 7A) is fed from a suitable web feedingdevice 80 (e.g., unwound from a roll) to a web alignment device 82 asindicated in the flow chart in FIG. 10. In one suitable embodiment, theweb has a width sufficient to make four pairs of pouches 10 inside-by-side relationship (FIG. 11A-C). It is understood, however, thatthe width of the web can be sufficient to make more or fewer pairs ofpouches 10 in side-by-side relationship. From the web alignment device82 and as indicated in FIG. 10, the web is directed to a coding station84 wherein the web is laser coded (or otherwise printed) with indicia,e.g., batch number, expiration date, current time and date. It iscontemplated that other indicia can be printed on the pouch 10including, for example, the manufacturer's name, the trade name of theproduct, the generic name of the product, direction of use, nutritionalinformation of the product, and/or quantity of the product. The web isthen fed to a laser scoring station 86 wherein the web is scored alongthree longitudinal lines (FIGS. 10 and 11A) to delineate the fourseparate pairs of pouches.

The web next enters a sterilization station 88 wherein the web passesthrough a peroxide bath, thereby sterilizing the entire web, as bothsides of the web are brought into direct contact with a peroxidesolution. It is contemplated that other sterilants (e.g., oxonia) orforms of sterilization (e.g., UV light, electron beam) can be used. Oncethe web has passed through the peroxide bath, the web is dried byblowing sterile air thereon at a drying station 90. While still in asterile environment, the web is directed to a web separation station 92and a web folding station 94. More specifically, the web is separatedinto four lanes at the web separation station 92 as it is pulled acrossrespective forming collars. Each of the four lanes is defined bysegments of the web. Each of the web segments are folded by therespective forming collar. Thus, in the described embodiment, the fourforming collars both separate the web into segments and fold thesegments. In other words, the four forming collars collectively defineboth the web separation station 92 and the web folding station 94. It isunderstood, however, that the web separation station 92 and the webfolding station 94 can be separate, discrete stations. It is alsounderstood that the forming collars can be any suitable device(s)capable of dividing the web into a plurality of web segments and foldingeach of the web segments.

As illustrated in FIG. 11B, the respective forming collar folds each ofthe side edges of the respective web segment inward (i.e., in thedirection of the arrows of FIG. 11B) toward the longitudinal center lineof the web segment at the folding station 94. As seen in FIG. 11B, eachof the web segments are folded about a fill pipe. After the web segmentis folded longitudinally, each of the web segments are longitudinallyheat sealed at a longitudinal seal station 96 wherein the overlyingportion of the web segment is bonded to the underlying portion of theweb segment along each of the side edges to form the side edge segments25 c of the seal lines 25.

Next, each of the web segments is perforated along a longitudinalperforation line located between the tubes of each of the web segmentsat a longitudinal perforation station 97 (FIGS. 10 and 11B). Once eachof the web segments move past a fill nozzle disposed on the respectivefill pipe, the web segments are directed to a horizontal sealing station99 wherein each of the web segments are heat sealed to sealingly bondthe overlying portion to the underlying portion of the blank to form oneof the end segments 25 a and the inboard seal segment 25 d of the seallines 25. As seen in FIG. 11C, two pouches 10, which are separated bythe perforated center line, are formed from each of the web segments andthe respective fill nozzle is disposed within the interior space of thepouch. The pouches 10 are then filled at a filling station 98 whereinboth of the pouches of each of the four web segments are filled with apredetermined amount of sterilized product. Next, each of the pouches 10is moved past the respective fill nozzle and is heat sealed shut, whichforms the other end segment 25 b of the seal lines 25, at the horizontalsealing station 99. The lines of weakness 30, 32 for each of the pouches10 are formed at a tear notch and cutting station 302.

After the pouches 10 are filled with product and sealed, they aretransferred to weight and leak inspection stations 304 wherein each ofthe pouches 10 are weighed and checked for leakage. Pouches 10 that passinspection are incubated at an incubation station 305 and tested forspoilage at a spoilage inspection station 306. Then, pouches arepackaged in pluralities into suitable secondary packaging, e.g., opaquecardboard box 500, 500′ as illustrated in FIGS. 12, 16A and 16B at asecondary packaging station 307. FIGS. 12,16A and 16B illustratedifferent embodiments of suitable secondary packaging 500, 500′ for thepouches 10. Pouches 10 that fail inspection are discarded.

When the product is a liquid human milk fortifier (e.g., theconcentrated liquid human milk fortifier or the gelled human milkfortifier described above), the product can be sterilized by heattreatment via a high temperature short time (HTST) process or an ultrahigh temperature (UHT) process to sufficiently reduce the bioburdenbefore the pouches 10 are filled. The above described packaging processof a sterile product, allows some products (e.g., some embodiments ofthe concentrated liquid human milk fortifier and the gelled human milkfortifier described above) to maintain commercially sterility over anextended shelf-life without the need for refrigeration even if theproduct is low acid (i.e., has a pH greater than 4.6) and has wateractivity greater than 0.85.

In one embodiment, the liquid human milk fortifier is photosensitive.That is, the vitamins in liquid human milk fortifier will degrade moreslowly when not exposed to light, and conversely, will degrade morerapidly when exposed to light. When the liquid human milk fortifier isphotosensitive, the opaque cardboard box 500 inhibits the pouches 10container therein from being exposed to light and thereby extends theshelf life of the liquid human milk fortifier.

Leak Detection Inspection System

In one suitable inspection station 304, each of the pouches 10 aretransferred through an in-line checkweigher were it is weighed. Anypouch 10 having a weight outside an acceptable weight range is rejected.The pouches 10 that pass the inline checkweigher are aligned andconveyed into a high voltage leak detection (HVLD) inspection system. Inthis system, the seal integrity of each of the pouches 10 isnon-destructively inspected by applying high voltage to the sealedliquid-filled pouch. The system is designed to conduct electric currentthrough the pouch 10 and measure the amount of current that passesthrough the pouch. A pouch 10 with a leak (i.e., a faulty seal) willtransfer more current to a ground electric than a pouch having a sealwith good integrity. The seals of the pouch 10 act as an insulator tothe liquid inside. Any pouch 10 that does not pass inspection (i.e., hasa current above an acceptable range) is automatically rejected.

More specifically, once the pouches 10 enter the high voltage leakdetection inspection system, they pass to a press that applies acompression force to each of the pouches. The compression force pushesliquid into any weak areas of the pouch body and/or pouch seal. Whilecompressed, each of the pouches 10 is conveyed past a series of rollersand metal electrode brushes in the inspection station wherein highvoltage power is applied the pouches. In one suitable configuration, thevoltage is transferred from an upper electrode positioned above thepouch through the pouch 10 to ground electrode positioned beneath thepouch. In other words, the pouch 10 completes the circuit between theupper electrode and the ground electrode, which provides a measurablevolume of electric current through the pouch.

A pouch 10 with good seal integrity will provide a lower voltage outputas compared to a pouch with poor seal integrity, which provides a highervoltage output. Thus, the high voltage leak detection inspection machinedetermined if each of the pouches 10 is “good” or “bad” based on themeasured voltage relative to a voltage threshold, which is apre-determined set point. If the measured voltage is below thethreshold, the pouch will be transferred to an outfeed conveyor forsubsequent secondary packaging. If the measured voltage is above thethreshold, the pouch 10 will be transferred to a reject bin.

Secondary Container

In one suitable embodiment, the cardboard box 500 (broadly, thesecondary container) includes a generally rectangular base section 502and a lid 501 hingely attached to the base (FIGS. 12 and 17-21). Thebase section 502 and lid 501 are indicated generally by their respectivereference numbers. The base section 502 includes a bottom wall 504, fourside walls 506 extending up from the bottom wall, and a top wall 508. Asseen in FIG. 21, the top wall 508 of the base section 502 extends alongonly a portion of a length of the box 500. For example, in theillustrated embodiment, the box 500 has a length L of about 12 cm andthe top wall 508 has a length L′ of 2.5 cm. It is understood that thebox 500 and top wall 508 can have different lengths. It is alsounderstood that the ratio between the length of the box 500 and thelength of the top wall 508 can be different. It is further understoodthat the box 500 can be shaped other than rectangular and be constructedfrom other suitable materials (e.g., plastic).

The lid 501, which is formed integrally with the base section 502, hasan upper wall 510 and a pair of tapered sidewalls 503 extending downwardfrom the upper wall. An end wall 505 extends downward from the upperwall 510 and between the sidewalls 503. The lid 501 is pivotally about aliving hinge 507 between a closed position (FIGS. 17-19) and an openedposition (FIGS. 12, 20 and 21). The living hinge 507 is located betweenthe top wall 508 of the base section 502 and the upper wall 510 of thelid 501. In one suitable embodiment, the weight of the lid 501 issufficient to bias the lid about the living hinge toward to the closedposition. The end wall 505 of the lid 501 includes a tab 511 adapted forinsertion into a slot 513 in one of the side walls (i.e., a front wall)of the box 500 for holding the lid 501 in the closed position. The tab511 can be seen inserted into the slot 513 in FIG. 17. It is understoodthat the lid 501 can be hingely attached to the base section 502 inother suitable manners besides the illustrated living hinge 507. It isfurther understood that the lid 501 can be formed separate from the basesection 502 and attached thereto.

A pair of hold-downs 509 are located adjacent the ends of the livinghinge 507 to provide rigidity and support to the box 500 about theliving hinge. In the illustrated embodiment, each of the hold-downs 509are flaps that extend outward from the top wall of the base section 502.Each of the flaps are folded about a pair of fold-lines and insertedinto an associated slot in one of the sidewalls of the base section(FIG. 21). One of the fold-lines is adjacent the top wall 508 of thebase section 502 and the other is adjacent the slot in the respectivesidewall. Each of the flaps includes a head portion (not shown) toinhibit the flap from being pulled (or otherwise withdrawn) from theassociated slot.

As seen in FIGS. 12 and 20, an interior floor 521 of the box 500 istented or peaked along its center line 533. That is, the interior floor521 is highest at its center and slopes downward toward each of itssides. In one suitable embodiment, the interior floor 521 of the box 500is defined by an insert that is formed separate from the othercomponents of the box and rest on top of the bottom wall of the basesection. It is, understood, however, that the interior floor 521 can beformed integrally with another component of the box 500, such as, thebottom wall of the base section.

Method of Use

In use, a user removes a pair of the joined pouches 10 from thecardboard box 500 of FIG. 12 (or the cardboard box 500′ of FIGS. 16A and16B) and separates them by tearing along the perforated center line thatdivides the two, joined pouches. Once the pouches 10 are separated, theuser inspects the contents of one of the pouches through the transparentfront and back panels to determine if the product has separated orspoiled. If the product has separated (or mixing is otherwise desired),the user can manually knead (or otherwise manipulate) the product withinthe pouch 10 as described above to thoroughly mix the product insitu.Once the user observes that the product is thoroughly mixed, the usermanually grips the pouch 10 by its grip portion 66 and tears the gripportion along the lines of weakness 30, 32 to completely remove the gripportion from the pouch 10. In doing so, the user opens the pouch 10 bytearing through the spout 62 to form the spout opening 63 (FIGS. 6 and15).

The product can be poured or squeezed from the pouch 10. In oneembodiment, the product is a consumable product that can be consumeddirectly from the pouch 10. In another embodiment, the product is aconsumable product intended to be mixed with another product. Forexample, if the product is a human milk fortifier (e.g., theconcentrated liquid human milk fortifier or the gelled human milkfortifier described above), the human milk fortifier can be dispenseddirectly into a container (e.g., infant bottle B) containing human milkM (or other suitable infant formula) as illustrated in FIG. 13. In suchan embodiment, the resulting fortified human milk or fortified infantformula is suitable for oral feeding to an infant, including a prematureinfant.

General

All percentages, parts and ratios as used herein, are by weight of thetotal composition, unless otherwise specified. All such weights as theypertain to listed ingredients are based on the active level and,therefore, do not include solvents or by-products that may be includedin commercially available materials, unless otherwise specified.

Numerical ranges as used herein are intended to include every number andsubset of numbers within that range, whether specifically disclosed ornot. Further, these numerical ranges should be construed as providingsupport for a claim directed to any number or subset of numbers in thatrange. For example, a disclosure of from 1 to 10 should be construed assupporting a range of from 2 to 8, from 3 to 7, from 5 to 6, from 1 to9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.

All references to singular characteristics or limitations of the presentdisclosure shall include the corresponding plural characteristic orlimitation, and vice versa, unless otherwise specified or clearlyimplied to the contrary by the context in which the reference is made.

All combinations of method or process steps as used herein can beperformed in any order, unless otherwise specified or clearly implied tothe contrary by the context in which the referenced combination is made.

When introducing elements of the present invention or the preferredembodiment(s) thereof, the articles “a”, “an”, “the” and “said” areintended to mean that there are one or more of the elements. The terms“comprising”, “including” and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements.

As various changes could be made in the above constructions withoutdeparting from the scope of the invention, it is intended that allmatter contained in the above description or shown in the accompanyingdrawings shall be interpreted as illustrative and not in a limitingsense.

1-15. (canceled)
 16. A single-use pouch comprising: a web folded to forma pouch having a front panel, a back panel, a top edge, a bottom edge,and two side edges, wherein the top edge, the bottom edge and one of thetwo side edges are sealed, the other of the two side edges is a foldline, and the front panel and the back panel define an interior space;and a liquid product contained in the interior space; wherein theinterior space includes a body and a spout, one side of the spoutdefined by the fold line, and the spout in fluid communication with thebody and through which the product is dispensed from the pouch.
 17. Thesingle-use pouch of claim 16 wherein the fold line acts as a channel toguide liquid product from the body towards an opening at the end of thespout.
 18. The single-use pouch of claim 16 wherein a width of the pouchis at least three times a width of the spout.
 19. The single-use pouchof claim 16 wherein the interior space includes a transition portionconnecting the spout and the body, wherein the transition portiondefines a travel path for the liquid product, and the travel path is atan angle to the fold line.
 20. The single-use pouch of claim 16 whereinat least one of the front panel and the rear panel includes a line ofweakness positioned between the top edge and the body, and in a pathtransverse to the spout.
 21. The single-use pouch of claim 16 furthercomprising a gripping portion positioned between the top edge and thebody.
 22. The single-use pouch of claim 21 wherein the gripping portionincludes a portion of the front panel sealed to a portion of the backpanel.
 23. The single-use pouch of claim 22 wherein at least one of thefront panel and the rear panel includes a line of weakness positionedentirely within the gripping portion.
 24. The single-use pouch of claim21 wherein the gripping portion defines a side of the spout opposite thefold line.
 25. The single-use pouch of claim 16 wherein the liquidproduct is aseptically processed.
 26. The single-use pouch of claim 16wherein the liquid product is a human milk fortifier.
 27. The single-usepouch of claim 16 wherein the liquid product is manually kneadablewithin the interior space.
 28. The single-use pouch of claim 16 whereinthe liquid product is visible through at least one of the front paneland the back panel.
 29. The single-use pouch of claim 28 wherein indiciais printed on the front panel and the back panel, and at least themajority of at least one of the front panel and the back panel istransparent.
 30. The single-use pouch of claim 16 wherein the web is amulti-layer plastic laminate.
 31. A single-use pouch comprising: amulti-layer plastic sheet folded to form a pouch having a front panel, aback panel, a top edge, a bottom edge, and two side edges, wherein thetop edge, the bottom edge and one of the two side edges are sealed, theother of the two side edges is a fold line, and the front panel and theback panel define an interior space; and an aseptically processed liquidproduct contained in the interior space; wherein the interior spaceincludes a body and a spout, one side of the spout defined by the foldline, and the spout in fluid communication with the body, wherein thefold line acts as a channel to guide liquid product from the bodytowards an opposite end of the spout.
 32. The single-use pouch of claim31 wherein at least one of the front panel and the rear panel includes aline of weakness positioned between the top edge and the body, and in apath transverse to the spout.
 33. The single-use pouch of claim 31wherein the line of weakness is positioned remotely from the spout. 34.The single-use pouch of claim 31 further comprising a gripping portionpositioned between the top edge and the body, the gripping portionincluding a portion of the front panel sealed to a portion of the backpanel.
 35. The single-use pouch of claim 34 wherein the gripping portiondefines a side of the spout opposite the fold line.